A 2-Part, Phase I, Single-Dose, 3-Period Crossover Relative Bioavailability Study of a Pediatric TRIUMEQ Dispersible Tablet and Pediatric Dolutegravir and Lamivudine (DTG/3TC) Fixed Dose Combination Dispersible Tablet Formulations as Compared With Adult Tablets in Healthy Volunteers
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资源简介:
This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of
pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions.
Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment
periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an
adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric
DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total
duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts,
may be run in parallel as they are independent of each other. TRIUMEQ is a registered
trademark of GlaxoSmithKline group of companies.
提供机构:
Vivli
创建时间:
2023-08-15



